Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

University of Sao Paulo

Status and phase: Unknown; Phase 4

Conditions: Schizophrenia or Schizoaffective Disorder

Treatments: Drug: Antipsychotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01016145

Projesq-IPAP

Details and patient eligibility

About

The objective of this study is to evaluate predictors of response to antipsychotic medication in subjects with schizophrenia. The investigators will evaluate psychopathology,brain MRI, genetics and neuropsychological profile. Two groups of treatment will be compared: first generation antipsychotics vs. second generation antipsychotics. Participants will be randomized to one of the groups. Trial duration: 12 weeks.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Schizophrenia or schizoaffective disorder
• Age: 18-45 years olde
• Less than 10 years of diagnosis
• Acute exacerbation of psychotic symptoms

Exclusion criteria

• Use of clozapine
• Clinical unstable disease
• Delirium and cognitive disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

First generation antipsychotic

Active Comparator group

Description:

Subjects randomized to this arm will receive treatment with haloperidol or chlorpromazine.

Treatment:

Drug: Antipsychotics

Drug: Antipsychotics

Second generation antipsychotics

Experimental group

Description:

Subjects randomized to this arm will receive treatment with a second-generation antipsychotic: risperidone or olanzapine or aripiprazole or quetiapine or ziprasidone

Treatment:

Drug: Antipsychotics

Drug: Antipsychotics